Phase I data on a “novel herbal therapy”

There is some media buzz around publication of the results of a Phase I trial of Zyflamend, a commercially available herbal concoction that is supposed to be able to “affect the inflammation responses and may serve an important function in promoting normal cell growth in the colon, pancreas, breast tissue, and other organ systems.” However, this information is not particularly new.

A report on ScienceToday states that:

In the study, 23 men ages 40-75 years-old who were diagnosed with high-grade prostatic intraepithelial neoplasia (HGPIN) at biopsy, lesions that indicate an increased risk of developing prostate cancer, were admitted into this prospective clinical trial, in order to determine the safety and tolerability of Zyflamend when administered orally for 18-months, either alone or along with various dietary supplements.

Unfortunately the Journal of the Society of Integrative Oncology (in which this paper was published) does not appear to make abstracts of its articles available on its web site. Furthermore, it is seems that no further trials of this product should be expected. There is no reference to any further clinical trial of this agent on the web site.

The only available clinical data from this study (which has been previously presented at ASCO and some other relevant symposia) tell us that this drug was safe when given to this small group of patients. It does not tell us (yet) that this drug can prevent progression from HG-PIN to prostate cancer. Additional, detailed information about Zyflamend is available on the herbal therapies section of the Memorial Sloan-Kettering Cancer Center web site.

There is, however, increasing evidence that the development of prostate cancer can be delayed or prevented in about 25 percent of the men currently being diagnosed with prostate cancer, as originally shown by the PCPT trial (using finasteride) and earlier this year by the REDUCE trial (which used dutasteride).

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